The present invention relates to the field of antimicrobial therapy.
Rifalazil, an ansamycin-class antibiotic, has been described in the U.S. Pat. No. 4,983,602, where its antibacterial activity has been disclosed. Dosages described in vitro and in mice animal models correspond to a dose from 10 mg per day to 10 g per day for adults. However, when clinical trials with these doses of the antibiotic were administered daily, many adverse reactions occurred and the treatment with rifalazil was discontinued.
More recently, a once or twice-a-week dosing regimen for rifalazil was found to be efficacious against mycobacterium species, as described in U.S. Pat. No. 6,316,433. This regimen included doses ranging from 1 to 100 mg of rifalazil once or twice weekly. This dosing regimen reduced, but did not eliminate, the incidence of adverse reactions, which include the development of headaches, fevers, and “flu-like” symptoms.